US finds contaminant in popular heartburn drug

FDA officials said the amount of the impurity barely exceeds levels found in common foods.

Author:
TEGNA Staff, MATTHEW PERRONE AP Health Writer

Published:
4:55 PM EDT September 13, 2019

Updated:
4:55 PM EDT September 13, 2019

WASHINGTON — The U.S. Food and Drug Administration said in a statement on their website Friday that they have "learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels."

Officials are investigating low levels of the potentially dangerous contaminant in the popular heartburn medication and related generic drugs.

For now, the FDA says patients can continue taking their medications.

The agency said it has detected a "probable" cancer-causing chemical in the medications, which are sold as both prescription and over-the-counter treatments to treat stomach acid and ulcers.

FDA officials said the amount of the impurity barely exceeds levels found in common foods. But the same chemical has been linked to dozens of recalls of prescription blood pressure drugs in the past year. The FDA is still investigating that issue and last month sanctioned a manufacturing plant in India that makes some of the ingredients used in the medications.

Zantac maker Sanofi said in a statement it "takes patient safety seriously, and we are committed to working with the FDA."

Sanofi logo

The FDA is responsible for ensuring that U.S. medicines are manufactured in safe, sanitary conditions. But regulators have struggled for years to inspect the supply chain as pharmaceutical production has spread globally.

For decades the FDA focused its manufacturing inspections on U.S. factories. But over time, most companies have moved their manufacturing overseas to take advantage of cheaper labor and materials. Today, roughly 80% of the ingredients used in U.S. drugs are manufactured abroad, primarily in India and China, according to the Government Accountability Office.

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